As stated earlier, there is a tremendous need for cancer patients to donate tissue for cancer research. If you are interested in doing so, you will be asked to sign an informed consent document. It is important for you to understand the issues below, so that you can appropriately balance any potential risks with the possible benefits.

The phrase “informed consent” refers to the process of communication between a patient and a physician to help the patient understand a proposed medical intervention and results in the patient’s authorization or agreement to undergo a specific medical intervention (American Medical Association).

In the context of research, it applies to a legally effective process indicated in the United States Health and Human Services Code of Federal Regulations (45 CFR 46.116 and 45 CFR 46.117)...

• In which a research participant or a legally-authorized representative receives all information necessary to make an informed decision,
• that has facilitated his or her understanding of what has been disclosed by providing the ability to ask questions about the research and through having questions asked of him or her to measure understanding,
• and that promotes a voluntary decision.

• What kinds of data will be collected and how the data will be used and stored
• The patient’s willingness to be contacted about the use of his or her biospecimens and/or data in future research studies
• Any benefit or potential risk to the patient, the patient’s family, and his or her community, e.g., whether there is a risk of stigmatization and discrimination based on research results
• Whether individual or aggregate research results will be released to the patient, the family, or the provider and, if so, the mechanism for communicating such
  results
• The type of research that will be conducted, e.g., concerning specific cancer type or looking at all possible disease conditions
• Possible benefit to the investigator or institution and information concerning potential conflicts of interest
• How the patient can discontinue participation and withdraw consent

While it is agreed that pathology departments within hospitals and medical centers are the “recognized legal guardians” of tumor blocks, the ownership of tissue question persists. This question also arises when scientists determine that tumors could prove useful for research purposes, in particular, to generate a “cell line.”

A recent bestseller entitled The Immortal Life of Henrietta Lacks by Rebecca Skloot chronicles the story of the first research cell line, called HeLa, created from the cells of a woman whose very aggressive cervical cancer took her life. The cell line made early advances in biomedical research possible, but ultimately prompted crucial questions about our beliefs and ethics.

It is important to note that many informed consent documents for use of tissue specimens will include template language that grants permission to the researcher for establishment of a cell line from the tumor of the patient/research participant. This document most often includes language declaring that the donor of the tissue has no right to any products resulting from the research.

“Content Developed September 1, 2012”